510(k) · Cleared
ClearedKit Mendec Spine and Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tecres S.P.A. · NDN Cement, Bone, Vertebroplasty
Cleared on Sep 21, 2006 as substantially equivalent to K042415 (Tecres S.P.A., 2005) after a 30-day review. Its family tree reaches back 4 generations to 2001. 18 later devices descend from it.
- Decided
- Sep 21, 2006
- Review
- 30 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002652 (2001). 5 ancestors in all. 18 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK002652 Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp. · 2001 · Recalled
- 3 generations backK033801 Kyphx HV-R, Model C01AKyphon, Inc. · 2004 · Recalled
- 2 generations backK041584 Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 2004 · Recalled
- 1 generation backK042415 Mendec SpineTecres S.P.A. · 2005
- This deviceK062452 Kit Mendec Spine and Delivery SystemTecres S.P.A. · 2006
- Descendant · cites it directly · 17 of its ownK063248 Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek · 2007
- Descendant · 2 generations on · 10 of its ownK070293 Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc. · 2007
- Descendant · 3 generations on · 9 of its ownK132817 Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014
- Descendant · 4 generations on · 4 of its ownK181262 SpineJack Expansion KitVexim SA · 2018
- Descendant · 5 generations on · 3 of its ownK202393 SpineJack Expansion KitStryker Corporation · 2020
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K063248Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek · 2007 · cites it directly17descendants
- K070293Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc. · 2007 · 2 generations on10descendants
- K132817Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014 · 3 generations on9descendants
- K181262SpineJack Expansion KitVexim SA · 2018 · 4 generations on4descendants
- K202393SpineJack Expansion KitStryker Corporation · 2020 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002652 | Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii | Stryker Corp. | 2001 | 1 |
| −3 | K033801 | Kyphx HV-R, Model C01A | Kyphon, Inc. | 2004 | 2 |
| −2 | K041584 | Kyphx HV-R Bone Cement, Model C01A | Kyphon, Inc. | 2004 | 2 |
| −1 | K042415 | Mendec Spine | Tecres S.P.A. | 2005 | — |
| 0 (this device) | K062452 | Kit Mendec Spine and Delivery System | Tecres S.P.A. | 2006 | — |
| +1 | K063248 | Arcuate Vertebral Augmentation System | Medtronic Sofamor Danek | 2007 | — |
| +2 | K070293 | Benvenue VCF Osteo Coil System | Benvenue Medical, Inc. | 2007 | — |
| +3 | K132817 | Kiva VCF Treatment System | Benvenue Medical, Inc. | 2014 | — |
| +4 | K181262 | SpineJack Expansion Kit | Vexim SA | 2018 | — |
| +5 | K202393 | SpineJack Expansion Kit | Stryker Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NDN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NDN device
- #1 K241775 XeliteMed VertehighFix High Viscosity Spinal…score 14.9 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042415 | Mendec SpineSummary page 2…(metastatic cancers, myeloma). PredicateDevice Information The predicate device is Mendec Spine (K042415). Device Description Kit Mendec Spine and delivery system contains an acrylic resin for vertebroplasty system. The acrylic resin… | 2005 |
What descends from it? (18)
See all 182 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K063248 (Medtronic Sofamor Danek, 2007) has gone furthest, with 17 descendants of its own.
- 4 other devices also cite its predicate K042415.
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NDN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NDN
90in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NDN
4in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDN
626in 2025
MAUDE reports naming product code NDN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 128 | 0 | 21 |
| 2008 | 1 | — | 0 | 39 |
| 2009 | 6 | 211 | 1 | 70 |
| 2010 | 5 | 215 | 0 | 396 |
| 2011 | 11 | 164 | 0 | 98 |
| 2012 | 7 | 90 | 0 | 89 |
| 2013 | 7 | 118 | 4 | 242 |
| 2014 | 7 | 106 | 0 | 231 |
| 2015 | 6 | 76 | 0 | 204 |
| 2016 | 4 | 154 | 0 | 182 |
| 2017 | 5 | 125 | 0 | 191 |
| 2018 | 3 | 111 | 0 | 144 |
| 2019 | 2 | — | 0 | 227 |
| 2020 | 4 | 157 | 0 | 212 |
| 2021 | 2 | — | 0 | 344 |
| 2022 | 2 | — | 0 | 270 |
| 2023 | 2 | — | 0 | 311 |
| 2024 | 3 | 90 | 0 | 454 |
| 2025 | 2 | — | 0 | 626 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Kit Mendec Spine and delivery system is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062452 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062452: Kit Mendec Spine and Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062452
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026